MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 95MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.038.095S

Device Problem Migration (4003)

Patient Problems Pain (1994); Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

On (b)(6) 2020 patient had undergone revision of tfna due to left intertrochanteric femur fracture with impending non-union and left femoral head, cut-out also/fracture femoral head.It was reported the patient had worsening pain with collapse of her intertrochanteric femur fracture in an uncontrolled manner.It appeared that lag screw had spun within the nail and fractured.This report involves one (1) tfna screw 95mm - sterile.This is report 2 of 3 for (b)(4).This product complaint (b)(4), is related to (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Therapy date (b)(6) 2020.Device evaluated by manufacturer, device manufacture date, event problem and evaluation codes: part # 04.038.095s, lot # h532161, release to warehouse date: 21 dec 2017, expiration date: 30 nov 2027, manufacturing location: (b)(4), no ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that here was no damage or defects with the tfna screw 95mm - sterile.Migration/backout/pull-out/subsidence condition was not confirmed as x-ray evidence photos were not provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for tfna screw 95mm - sterile.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TFNA SCREW 95MM - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15131113
• MDR Text Key: 296885298
• Report Number: 2939274-2022-03021
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982098498
• UDI-Public: 10886982098498
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.038.095S
• Device Catalogue Number: 04.038.095S
• Device Lot Number: H532161
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN.; TFNA FEM NAIL Ø11 130° L170 TIMO15.
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female